EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.
Presentation on EU RoHS2 and Its Impact on the Medical Device Industry
Leo Eisner will be presenting on the topic “RoHS2 and Its Impact on the Medical Device Industry” at an FX Conferences event on 17 Dec, 2013 (Tues) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
RoHS Recast Implications to EU Med & IVD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU. You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF. With the exception of
Recasted RoHS Directive will apply to Med Dvcs & IVDs
This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011. We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU). Medical device manufacturers should be
Firms (i.e. Dell, HP, Sony, etc.) Urge EU Restrict Add’l Substances (BFRs & PVCs) in RoHS by 2015
Firms (i.e. Dell, HP, Sony, etc.) Urge EU Restrict Additional Substances (all brominated flame retardants (BFR) and polyvinyl chloride {PVC}) in RoHS for Electronic Devices by 2015 http://ht.ly/1SFNl